HPTN 069 NEXT-PrEP Launches
HPTN 069, Novel Exploration of Therapeutics for PrEP (NEXT PrEP), is a Phase II, multisite study designed to evaluate the safety and tolerability of alternative drugs for pre-exposure prophylaxis (PrEP) to prevent HIV transmission in a population of at-risk men who have sex with men (MSM) in the United States.
There are at least nine efficacy studies of PrEP either recently completed or currently underway in 15 countries involving over 20,000 individuals with diverse risk behaviors. All of these clinical trials evaluate PrEP using two drug formulations, either tenofovir disoproxil fumarate (TDF) or a fixed-dose combination of TDF/emtricitabine (FTC).
Despite encouraging findings from several of these studies, some concerns exist.
TDF/FTC (trade name TruvadaŽ) is used commonly in antiretroviral therapy (ART) regimens for treatment of HIV-infected individuals, and viral strains that are resistant to TDF and/or FTC exist and are transmitted in the community. In addition, although TDF with or without FTC is generally well-tolerated in both HIV-infected individuals and healthy volunteers using PrEP, concerns remain about long term side effects of these drugs, including possible kidney damage and loss of bone density.
New HIV prevention options remain critical.
HPTN 069 (NEXT-PrEP) will use regimens that include the following antiretroviral drugs alone or in combination drugs:
ˇ maraviroc (MVC),
ˇ emtricitabine (FTC),
ˇ tenofovir disoproxil fumarate,
ˇ and matching placebos.
Participants will be randomized to one of four arms including a TruvadaŽ arm.
The study will enroll four hundred men from the U.S. at sites in the following locations:
ˇ Baltimore, MD;
ˇ Boston, MA;
ˇ Chapel Hill, NC;
ˇ Cleveland, OH;
ˇ Los Angeles, CA;
ˇ New York City, NY;
ˇ Philadelphia, PA; Pittsburgh, PA;
ˇ San Francisco, CA;
ˇ San Juan, PR;
ˇ Seattle, WA; (the UW ACTU is the site here in Seattle, fyi)
ˇ Washington, DC.
Sites are encouraged to enroll young adult MSM (aged 18-25) and/or MSM of color.
The study is expected to last approximately two years.
For more info, contact:
Michael Louella, Outreach Coordinator - UW ACTU
Harborview Medical Center
325 9th Ave, Box 359929
Seattle, WA 98104-2499
Source: UW ACTU